Kornimate/medical-research-clean huggingface dataset:
implementation of the pittsburgh infant brain injury score

Conditions: Brain Injury; Clinical Decision Support; Infant

Summary: this is an implementation study of the pittsburgh infant brain injury score (pibis) into the upmc children's hospital of pittsburgh emergency department. children less than 1 year of age presenting to the chp ed for symptoms which place them at increased risk for aht as defined in the pibis validation study will be potentially eligible.

abusive head trauma is the leading cause of death due to physical abuse. missing the diagnosis of abusive head trauma (aht), particularly when it less severe is common and contributes to increased morbidity and mortality. over the past 10 years, the investigators have derived and subsequently prospectively validated the pittsburgh infant brain injury score (pibis), a point of care clinical decision rule to help physicians determine when it is appropriate to obtain neuroimaging in infants who present to the ed for evaluation of soft neurologic signs such as vomiting and fussiness. the results of the nih multi-center prospective validation were published in 2016 in pediatrics. the next step in evaluating pibis as a clinical prediction rule is to perform an implementation study. children less than 1 year of age presenting to the chp ed for symptoms which place them at increased risk for aht as defined in the pibis validation study will be potentially eligible. discrete fields in the electronic health record - including patient age, emergency severity index (esi), glasgow coma scale (gcs) score, temperature and chief complaint - will be used to identify potentially eligible children in a systematic and efficient manner. children who are potentially eligible based on this initial screen will trigger an alert to the nurse who will then complete a brief powerform to ensure eligibility and assess for inclusion/exclusion criteria. due to the nature of the research, the investigators will seek a waiver of informed consent as has been done in similar studies at our institution and others. at this point, eligible children will be considered enrolled. for children enrolled during the intervention period, providers will be presented with a detailed decision support strategy which encourages - but does not require - use of the pibis to make clinical decision re: the need for neuroimaging. for children enrolled during the control period, no other clinical decision support will occur. the duration of this evaluation period will be 24 months.

Eligibility criteria:
inclusion criteria: * age 30 days to less than 1 year * chief complaint of apnea, brue, fussiness or irritability, lethargy, neurologic complaint, poor feeding-acute, seizures/spells, or vomiting alone * first temperature in the ed less than or equal to 38.3c * acuity level/esi of 3, 4, or 5 exclusion criteria: * history of trauma related to this ed encounter * parent reported temperature of greater than 38.3c in the prior 24 hours * prior abnormal neuroimaging * previously enrolled in this study within preceding 28 days * provider preference for any reason
liberal or adhere to recommendations for pcc management in major bleeding following trauma

Conditions: Traumatic Bleeding

Summary: severe post-traumatic bleeding remains a major challenge in trauma management . the effectiveness and safety of pcc in the treatment of major traumatic bleeding is controversial, and the indications for use are not clear. studies on the status of pcc use and the efficacy evaluation of pcc adhere to recommendations are lacking.

post-traumatic severe bleeding and associated traumatic coagulopathy remains a challenge. the use of prothrombin complex concentrate (pcc) is being explored in the management of on-going coagulopathy following trauma, with the cited purpose of boosting thrombin generation. clinical data on the efficacy of pcc as part of a coagulation factor concentrate-based haemostatic strategy showed initial promising results in retrospective studies and meta-analysis. certainly, the utility of pcc was a residual question in the management of traumatic coagulopathy. uncertainty remains on the indication of use.the 2019 guideline on management of major bleeding and coagulopathy following trauma suggest that pcc should be administered to the bleeding patient based on evidence of delayed coagulation initiation using vem, provided that fibrinogen levels are normal. the recommendation grade is 2c.studies on the status of pcc use and the efficacy evaluation of pcc adhere to recommendations are lacking.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years old or \< 80 years old 2. trauma treated in resuscitation unit/emergency room patient 3. hospital admission within 24h after injury 4. assessment of blood consumption (abc) score ≥2 points. exclusion criteria: 1. pcc was used before admission 2. anticoagulant drugs (such as low molecular weight heparin, rivaroxaban, warfarin, etc.) 3. previous venous thrombosis (vte, patients with a history of coronary artery stents within 3 months of pulmonary embolism and myocardial infarction) 4. patients with traumatic cardiac arrest in hospital 5. women during breastfeeding, pregnancy or pregnancy 6. patients with hemophilia a and other blood system diseases, severe liver disease, cirrhosis and other coagulation dysfunction

Keywords: trauma major bleeding
b0151005 open-label extension study

Conditions: Crohn's Disease

Summary: this is a multi-center phase 2, open label, safety extension study in subjects with moderate to severe cd who are anti-tnf inadequate responders. subjects eligible for this study will have completed the 12-week induction period of study b0151003 and will be enrolled as either responders or non responders.


Eligibility criteria:
inclusion criteria: * subjects previously enrolled in study b0151003 and completed the blinded 84 day (12 week) induction period. * subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. * women of childbearing potential, who have sexual intercourse with a non surgically sterilized male partner, must agree and commit to the use highly effective methods of birth control from signing of the icd through 26 weeks after the final study evaluation or for 62 weeks from the last dose of investigational product for any subject who terminates early from this study. exclusion criteria: * subjects that have completed day 84 (week 12) of study b0151003, and experienced serious event(s) related to the investigational product, an unstable medical condition, or any other reason, in the opinion of the investigator, would preclude entry or inclusion in this study. * other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate entry into this study. * received any prohibited treatment during study b0151003 that, in the opinion of the investigator, compromised the safety or efficacy of this study.

Keywords: crohn's disease safety efficacy pharmacokinetics pharmacodynamics crohn's disease activity index (cdai)
management of insomnia in breast cancer patients

Conditions: Insomnia; Fatigue

Summary: to provide preliminary data on the effects of brief behavioral therapy for insomnia (bbt-i) on insomnia in breast cancer patients expecting to receive cancer treatment (unspecified). participants will be randomized into 4 groups: * arm 1: brief behavioral treatment of insomnia (bbt-i) + armodafinil 150 mg/day. * arm 2: behavioral therapy for insomnia (cbt-i) + armodafinil 150 mg/day. * arm 3: brief behavioral treatment of insomnia (bbt-i) without pharmaceutical intervention. * arm 4: behavioral therapy for insomnia (cbt-i) without pharmaceutical intervention.

the purpose of this study is to test the efficacy of brief behavioral treatment of insomnia (bbt-i) in the treatment of insomnia in humans. insomnia is an extraordinarily common problem for cancer patients that is often associated with diminished social and vocational functioning and qol. it is also likely that insomnia exacerbates other cancer-related symptoms (eg, fatigue, nausea, depressive mood, pain and/or reduced pain tolerance) and thus gives rise to the possibility of additive or multiplicative interactions. it is possible that untreated insomnia in the context of cancer therapy may lead to chronic forms of insomnia in cancer survivors which, in turn, independently confers risk for increased psychiatric and medical morbidity. thus, insomnia, by itself, is a significant problem that requires better understanding in order that its high prevalence can be reduced. developing interventions that might prevent onset of insomnia in breast cancer patients is vital.

Eligibility criteria:
inclusion criteria * be scheduled for cancer treatment with chemotherapy or biologics (prior chemotherapy and/or diagnosis of metastatic breast are allowed) * have at least 6 weeks of treatment remaining * ≥ 21 years old * able to understand written and spoken english * able to swallow medication (until amendment omitting armodafinil treatment) * score of 3+ on the sleep disruption evaluation form, or a score of 8+ on insomnia severity index (isi) exclusion criteria * prior treatment with armodafinil or modafinil (until amendment omitting armodafinil treatment) * prior treatment with psycho-stimulant medication within the past 28 days (until amendment omitting armodafinil treatment) * prior treatment with antiseizure medications (until amendment omitting armodafinil treatment) * has continuously taken sleep medication daily for the last 28 days (until amendment omitting armodafinil treatment) * history (self-reported) of unstable medical or psychiatric illness (within the last 5 years) * history of uncontrolled, cardiac disease, hypertension, severe headaches, glaucoma, or seizures (until amendment omitting armodafinil treatment) * pregnant or nursing * history of substance abuse or meet criteria for current alcohol abuse or dependence * history (self-reported) of chronic, preexisting insomnia, sleep apnea, or restless leg syndrome (rls) * severe hepatic impairment (until amendment omitting armodafinil treatment)
post-marketing clinical follow-up of the medical device diva®

Conditions: Lumbar Disc Herniation

Summary: observational, ambispective, longitudinal, comparative, open, multicentric study. the main objective is to compare the performance of care in patients operated with and without diva®.

the primary endpoint is the reoperation for any cause (excluding trauma) on the lumbar spine.

Eligibility criteria:
inclusion criteria: * adult patient, having undergone surgery for a degenerative or traumatic mono-segmental lumbar disc herniation, without any other associated pathology, operated with or without a diva® implant; * patient operated for at least 12 months; * patient able to understand the information related to the study; * patient having indicated his/her non-opposition to the collection of his/her personal data. exclusion criteria: * history of pathologies, malformations or surgical interventions on the spine; * patient belonging to the first 30 operated by the surgeon with the diva® implant; * protected patient (under legal protection, or deprived of liberty by judicial or administrative decision); * patient not benefiting from a social security scheme.
balance training with stroboscopic vision

Conditions: Ankle Inversion Sprain; Proprioceptive Disorders

Summary: balance training with stroboscopic vision in patients with chronic ankle instability.

this study was a single-blinded randomized controlled trial with two intervention groups consisted in multimodal balance training, multimodal balance training in addition to stroboscopic glasses and control group who received no intervention.

Eligibility criteria:
inclusion criteria: * a previous episode of ankle sprain in at least 6 months before the beginning of the study * a score of 25 or less in the cumberland ankle instability tool * no history of others musculoskeletal injuries in the lower limbs exclusion criteria: * an acute ankle sprain within the last six weeks * recent lower limb surgery
evaluation of sarcopenia in patients receiving home health care

Conditions: Sarcopenia; Home Health Care

Summary: the aim in the study is to evaluate the presence of sarcopenia in patients receiving home health care; to evaluate the relationship between sarcopenia and age, disease duration, and cause of immobility. in the literature review, a limited number of studies evaluating sarcopenia in home health patients were found.

home health service is the provision of health services needed by immobile and chronic disease patients in the home environment. the purpose of this service is not to diagnose the patient, but rather to follow up, implement and educate the treatment of the diagnosed patient. the aim of the study is to evaluate the presence of sarcopenia in patients receiving home health care; to evaluate the relationship between sarcopenia and age, disease duration, and cause of immobility. in the literature review, a limited number of studies evaluating sarcopenia in home health patients were found.

Eligibility criteria:
inclusion criteria: 1. receiving home health care 2. being at the mental and physical activity level to be able to perform and complete the tests 3. being 18-85 years old exclusion criteria: 1) patients who cannot cooperate

Keywords: sarcopenia home health care
abdominal belt use to treat low back pain

Conditions: Chronic Low Back Pain

Summary: objectives: to assess the effectiveness of an abdominal belt in the treatment of chronic mechanical-postural low back pain. methods: a randomized controlled trial was carried out, involving 60 consecutively selected patients with chronic low back pain randomly allocated to an intervention group (use of abdominal belt) and control group (non-use of abdominal belt). patients were evaluated at the baseline of the study (t0) as well as 1 (t1), 3 (t3) and 6 months (t6) after the inclusion. the patients were assessed for: pain (vas); functional capacity (roland morris), patient satisfaction (likert scale); and number of anti-inflammatory pills ingested. intention-to-treat analysis was also used. hypothesis - abdominal belt will improve pain in chronic low back pain patients


Eligibility criteria:
inclusion criteria: * patients from both genders, * between 18 and 65 years of age, * who sought medical care for a complaint of lumbar pain, * diagnosed with chronic low back pain, with vas for pain between 4 and 8 cm (0-10), * who agreed to participate in the study and signed terms of informed consent. exclusion criteria: * diagnosis or under diagnostic investigation of low back pain from secondary causes (spondyloarthopathy, infection, neoplasm, complete sciatica), * fibromyalgia, * previous spinal surgery, * litigation (patients on leave from work or in work leave processes due to low back pain); * having changed physical activity in previous three months; * body mass index (bmi) higher than 30; * acupuncture treatment or physiotherapy in the previous three months

Keywords: abdominal belt chronic low back pain pain functional capacity
development of hardware and software for pulmonary magnetic resonance imaging using inhaled tracer gases

Conditions: Healthy Volunteers

Summary: this is a single centre study. the overarching hypothesis of this study is that mri with inhaled tracer gases can provide high quality images of lung function to complement conventional 1h mri. the study interventions do not affect the standard of care.

respiratory diseases are a significant healthcare burden worldwide. in canada, this is expected to increase. non-invasive medical imaging tests are able to provide regional functional and structural information of the lung and may aid in the diagnosis and treatment of respiratory diseases. current examples include chest x-ray, x-ray computed tomography (ct), and nuclear medicine techniques. however, these techniques suffer from various associated limitations. x-ray based methods offer high resolution and rapid acquisitions, but only reflect lung structure and anatomy by measuring tissue density. nuclear medicine techniques may be used to measure lung function but suffer from poor resolution and long acquisition times. furthermore, both x-ray based and nuclear medicine imaging techniques make use of ionizing radiation, which may not be suitable for longitudinal imaging, or imaging in vulnerable populations such as children. conventional magnetic resonance imaging (mri) images the 1h nucleus (proton) attached to water molecules in biological tissues. mri can provide high-resolution anatomical and functional information of the lung with multiparametric contrast without the use of ionizing radiation. however, major drawbacks associated with conventional 1h mri of the lung are the low tissue density, large magnetic susceptibility differences between numerous air/tissue interfaces, and image corruption by cardiorespiratory motion during the necessarily long image acquisition time frame. wo;; one strategy which may be employed to overcome the limitations associated with conventional 1h mri is the application of safe mr-sensitive inhaled tracer gases. this allows for the direct visualization of the spatial distribution of these gases, revealing regional ventilation directly. in this study we aim to develop, implement, and test these technologies for improved in-vivo imaging of lung structure and function in adults and children with no history of respiratory disease.

Eligibility criteria:
inclusion criteria: * consent provided * aged 6-75 years old * in good general health as evidenced by medical history * meets mri screening criteria exclusion criteria: * has diagnosis of pulmonary disease * fev1 \<70% * requires supplemental oxygen * has had a respiratory infection within the past 2 weeks * pregnant or lactating\*

Keywords: lung mri healthy hp xenon gas perfluoropropane gas
pulsed electromagnetic fields (pemfs) in complex regional pain syndrome type i (crps-i) of the foot (pecfoa)

Conditions: Pain, Joint; Complex Regional Pain Syndromes; Ankle Disease; Foot Diseases

Summary: the investigators hypothesize that the association of i-one® therapy with standard rehabilitation treatment can optimize the clinical and functional recovery of patients with pulsed electromagnetic fields (pemfs) (i-one® therapy) of the foot or ankle.

study design; spontaneous, prospective, randomized study with control group. purpose of the study: evaluate the functional clinical improvement of the foot/ankle joint with algodystrophic pathology following a standard rehabilitation treatment and home biophysical treatment and local biophysical stimulation with i-one® therapy (igea spa).

Eligibility criteria:
inclusion criteria: * diagnosis of type i crps according to the budapest criteria (table 1) * type i crps involving the ankle or foot * onset of crps type i up to a maximum of 3 years after the symptomatic event * pain on visual analog scale (vas) scale quantified as intensity at least ≥ 5 at recruitment * pharmacological treatment with first infusion cycle of neridronate exclusion criteria: * neurological pathologies (stroke, degenerative, traumatic pathologies) * local neurological impairment (type ii crps), confirmed by a conduction test or similar * cardiac pacemaker, treatment site malignancy

Keywords: complex regional pain syndromes foot ankle
effectiveness of a postal intervention to improve the use of ppi

Conditions: Drug Overdose

Summary: it was a randomised intervention study, with before-and-after outcome measures and a control group, in patients who had an active long-term prescription for ppis at high doses for at least 6 months.

the intervention consisted of sending patients an informative letter by post, in which their doctor invited them to seek an appointment for a medication review. control group patients did not receive such a letter, and they were treated as usual (their doctors received a list of identifiers of patients on high doses). the main outcome variable was the number of active prescriptions of each ppi dose (high dose/standard dose/treatment cessation) at 6 months after the intervention.

Eligibility criteria:
inclusion criteria: * patients under the care of our organisation who in may 2017 had an active long-term prescription for ppis at high doses for at least 6 months. exclusion criteria: * patients whose gps declined to participate
s9700 combination chemotherapy in treating patients with stage ii or stage iii pancreatic cancer

Conditions: Pancreatic Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. chemotherapy following surgery may be an effective treatment for pancreatic cancer. purpose: phase ii trial to study the effectiveness of combination chemotherapy in treating patients with stage ii or stage iii pancreatic cancer that has not been surgically removed.

objectives: i. assess the one year overall survival rate of patients with advanced, unresectable pancreatic cancer treated with fluorouracil, leucovorin, mitomycin and dipyridamole. ii. assess the response rate in this group of patients. iii. evaluate the frequency and severity of the toxic effects associated with this therapy. iv. assess the rate of resectability in patients who respond to therapy. outline: all patients undergo surgical placement of an indwelling central venous line. patients receive fluorouracil iv by continuous infusion on days 1-28, leucovorin calcium iv on days 1, 8, 15, and 22, oral dipyridamole on days 1-28, and mitomycin iv every 6 weeks starting on day 1. treatment repeats every 6 weeks for 4 courses. patients with a partial or complete response are reevaluated for possible surgical resection. resected patients resume chemotherapy 4-8 weeks after surgery for an additional 16 weeks. patients are followed every 6 months for 2 years, then annually until death. projected accrual: a total of 55 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically or cytologically proven stage ii or iii pancreatic adenocarcinoma ductal adenocarcinoma mucinous noncystic carcinoma signet ring cell carcinoma adenosquamous carcinoma undifferentiated (anaplastic) carcinoma mixed ductal-endocrine carcinoma well differentiated adenocarcinoma moderately well or poorly differentiated adenocarcinoma undifferentiated ductal carcinoma must have unresectable and localized disease measurable or evaluable disease patient characteristics: age: not specified performance status: swog 0-2 life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified other: not pregnant or nursing fertile patients must use effective contraception loss of no greater than 15% of actual body weight oral intake of greater than 1,200 calories per day no other malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or any stage i or ii cancer that is currently in complete remission prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior systemic chemotherapy for pancreatic cancer endocrine therapy: not specified radiotherapy: no prior radiation therapy for pancreatic cancer surgery: at least 2 weeks since prior surgical bypass procedure and recovered

Keywords: stage ii pancreatic cancer stage iii pancreatic cancer duct cell adenocarcinoma of the pancreas